Rodriguez 2007.
Methods | Design: randomised, double blind, parallel group study Duration: 2‐day run in, then 21‐day treatment period Setting: not stated |
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Participants | Persistent moderate or severe cancer pain (primarily gastric, breast, prostate, lung) N = 177 M 88, F 89 Mean age 60 years |
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Interventions |
If no PR (VAS ≥ 4/10) dose could be doubled. If this caused intolerable adverse events it could be reduced by 25% Rescue medication: |
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Outcomes | PI: 10 cm VAS PR: five‐point scale (0‐4) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated schedule" |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "study drugs had similar characteristics such as color, shape, and dimensions and were packaged in identical containers" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "study drugs had similar characteristics such as color, shape, and dimensions and were packaged in identical containers" |
Incomplete adverse event outcome data‐ patient level | Low risk | <90% participants included |
Selective reporting bias for adverse events | Low risk | Comprehensive list |
Size | Unclear risk | 50 ‐ 199 participants per treatment arm |